Disappointing Day For Alexza Pharmaceuticals

Image via CrunchBaseI quietly predicted today's FDA outcome on Alexza and Jazz Pharma's CRL, last week in my FDA Calendar prediction.  Here were My Predictions which stated that investor's should be shorting Alexza last week.  That would have netted a huge profit on Alexza's demise.  I think that shorting stocks or place put call options on FDA catalyst events can be profitable if done properly.  Although Jazz did not go down today, I do not see good things for their future

You really have to know what you are doing though when you make projections like this as is the drugs are approved then you will not be too happy with the results.  It's really a difficult line to cross but I see the value of Shorting Stocks under the Obama FDA panel.  The panel has rejected 4 drugs so far in October. 

That doesn't mean that you should have shorted Hospira or Human Genome Sciences (HGSI) because these are large and mid cap stocks that are affected less by these FDA decisions.  Human Genome has an upcoming drug approval in December for their Lupus therapy and I actually like the stock right now and consider it a buy.  Alexza and Jazz just had too many red flags for me for approvals.  You have to do your homework and look through the clinical trial data available.  Or just follow BioPharma Investor and let me give you helpful advice on these decision. 

Wikinvest--Alexza Pharmaceuticals (ALXA)  Closed:  1.35 Down 1.65 for a 54.46% Loss

Wikinvest--Jazz Pharmaceuticals (JAZZ)  Jazz will probably will be going down with today's CRL.

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia


FDA O-Fer October Drug Approvals

BOSTON (TheStreet) -- U.S. regulators have to approve at least one new drug in October, right?


The U.S. Food and Drug Administration has a perfect 0-4 record so far this month -- four drug approval decisions, four drug rejections. Monday, Alexza Pharmaceuticals(ALXA) and Jazz Pharmaceuticals(JAZZ) received the bad news. Last week, it was FDA rejections for Human Genome Sciences(HGSI) and Hospira(HSP).

Perhaps the best shot for more positive news will come Tuesday when Alkermes(ALKS) is expecting FDA to rule on its drug for opioid addiction.

Alexza Pharmaceuticals Oct 11th FDA Decision for Staccato Technology

Image via Wikipedia Time to start buying more shares of Alexza Pharmaceuticals (ALXA). Another promising run-up play for October is Alexza Pharmaceuticals and its lead candidate AZ-004, which is an inhalation product candidate for the rapid treatment of agitation in patients with schizophrenia or bi-polar disorder. It has a PDUFA(FDA Decision) date of October 11th, 2010.

Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug

Image via CrunchBase Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug

I have actually changed positions on this stock and do not think it will be approved based on a conservative FDA panel under the Obama Administration.  I might change that opinion but we will have to see on This Weeks FDA panel meeting.
About the author: Sheff Station Sheff is a trader and investor of big board, small cap, and biotech stocks.

Avanir’s STAR trial gives clarity to the FDA for Oct 30th Decision.

Repost of Seeking Alpha Article on AVNR. Avanir has an upcoming FDA recommendation decision date on Oct. 30. We will see if they stick with that actual date for a Spooky Halloween Trade.

By: Sheff Station

Avanir’s STAR trial gives clarity to the FDA for Oct 30th Decision.

Jul 30, 2010 2:14 AM | about stocks: AVNR, ALXA, ARNA

In early 2006 AVNR filed a drug application for Zenvia. They had filed a submission for Zenvia with the 30/30 dose combination. Two Phase III studies demonstrated safety & efficacy of Zenvia in PBA as well as 10 clinical trials. Priority review was received from the FDA as they acknowledged it’s a disorder with a high unmet medical need. In late 2006 AVNR received an approvable letter from the FDA.

BioPharma List for Wednesday August 11th

Stocks that I will be following for the near future. Yesterday's market was down heavy due to the FED's recommendation but we will see how the market recovers Wednesday. The FED acknowledged the economy needs help and was cashing in mortgage securities into long-term treasury notes.

Here are stocks I am currently following for Wednesday and interested by near future events.

1. BSD Medical BSDM

Three Extreme FDA Medical Device / Diagnostic Trades
by: Mike Havrilla June 03, 2010

Monday's BioPharma List for August 9th

Top Pharmaceuticals for Monday August 9th

1. K-V Pharmaceuticals This one is slightly unpredictable (NYSE:KV.A) at 1.46 up +0.17 a 13.17% gain after having a 20.6% increase last week.

2. Roche Holdings RHHBF; F denotes a foreign stock trading on Nasdaq this quote is from last week as this stock trades based on a foreign market. Last week up 10.50 at 142.00 a 10.50% gain. The stock has been down as of late but I predict that things could change in the near future for the better.

Their US Based stock RHHBY was flat today. (RHHBY)